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    Summary
    EudraCT Number:2017-003317-25
    Sponsor's Protocol Code Number:LTS14424
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-10-25
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2017-003317-25
    A.3Full title of the trial
    One year study to evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study
    Ensayo de un año para evaluar la seguridad y tolerabilidad a largo plazo de dupilumab en pacientes pediátricos con asma que participaron en un ensayo clínico previo de dupilumab en asma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of the Safety and Efficacy of Dupilumab in Children with Asthma (Liberty Asthma Excursion)
    Evaluar la seguridad y la eficacia de Dupilumab en niños con asma (Liberty Asthma Excursion)
    A.4.1Sponsor's protocol code numberLTS14424
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1200-1757
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/021/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSanofi-aventis recherche & développement
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi-aventis recherche & développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointUnidad Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla 2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 94 00
    B.5.6E-mailes-unidadestudiosclinicos@sanofi.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namedupilumab
    D.3.2Product code SAR231893
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdupilumab
    D.3.9.2Current sponsor codeSAR231893
    D.3.9.3Other descriptive nameREGN668
    D.3.9.4EV Substance CodeSUB88511
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namedupilumab
    D.3.2Product code SAR231893
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdupilumab
    D.3.9.2Current sponsor codeSAR231893
    D.3.9.3Other descriptive nameREGN668
    D.3.9.4EV Substance CodeSUB88511
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number175
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asthma
    Asma
    E.1.1.1Medical condition in easily understood language
    Asthma
    Asma
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.
    Evaluar la seguridad y la tolerabilidad a largo plazo de dupilumab en pacientes pediátricos con asma que participaron en un ensayo clínico previo de dupilumab en asma (EFC14153)
    E.2.2Secondary objectives of the trial
    -To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.
    -To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab
    asthma clinical study with regard to:
    -Systemic exposure.
    -Anti-drug antibodies (ADAs).
    -Biomarkers.
    Evaluar la eficacia a largo plazo de dupilumab en pacientes pediátricos con asma que participaron en un ensayo clínico previo de dupilumab en asma.
    Evaluar dupilumab en pacientes pediátricos con asma que participaron en un ensayo clínico previo de dupilumab en asma, en referencia a lo siguiente:
    - Exposición sistémica
    - Anticuerpos antifármaco (AAF)
    - Biomarcadores.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Pediatric patients with asthma who completed the treatment in a dupilumab asthma trial (EFC14153).
    -Signed written informed consent/assent.
    I 01. Pacientes pediátricos con asma que hayan finalizado el tratamiento en un ensayo de dupilumab en asma (EFC14153)
    I 02. Consentimiento/asentimiento informado por escrito firmado.
    E.4Principal exclusion criteria
    -Any chronic lung disease other than asthma (eg, cystic fibrosis, bronchopulmonary dysplasia) which may impair lung function.
    -Inability to follow the procedures of the study/noncompliance (eg, due to language problems or psychological disorders).
    -Patients receiving concomitant treatment or required a new concomitant treatment prohibited in the study.
    -Patients or his/her parent(s)/caregiver(s)/legal guardian(s) is related to the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff thereof directly involved in the conduct of the study.
    -Patients who experienced any hypersensitivity reactions to dupilumab in a previous dupilumab study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
    -Any abnormalities or adverse events at screening (last treatment visit in the study EFC14153 will be the screening visit) that per Investigator judgment would adversely affect patient’s participation in this study or would require permanent IMP discontinuation.
    -For female patients who have commenced menstruating at any time during the study and are either:
    -Found to have a positive urine pregnancy test, or
    -Sexually active, not using an established acceptable contraceptive method.
    -Planned live, attenuated vaccinations during the study.
    -Patients with active autoimmune disease or patients using immunosuppressive therapy for autoimmune disease (eg, juvenile idiopathic arthritis, inflammatory bowel disease, systemic lupus erythematosus) at enrollment.
    E 01. Cualquier otra enfermedad pulmonar crónica distinta al asma (p. ej., fibrosis quística, displasia broncopulmonar) que pueda deteriorar la función pulmonar.
    E 02. Incapacidad para seguir los procedimientos del ensayo/incumplimiento (p. ej., debido a problemas de idioma o trastornos psicológicos).
    E 03. Pacientes que, en la visita de inclusión, estén recibiendo tratamiento concomitante o requieran un nuevo tratamiento concomitante prohibido en el ensayo.
    Si los pacientes o sus padres / cuidadores / tutores legales están relacionados con el Investigador o cualquier Subinvestigador, asistente de investigación, farmacéutico, coordinador del estudio, otros miembros del personal directamente involucrados en el estudio.
    E 04. Pacientes que han experimentado alguna reacción de hipersensibilidad al PEI en el ensayo previo de dupilumab en asma que, según el investigador, podría indicar que un tratamiento continuo con dupilumab pueda representar un riesgo inaceptable para el paciente.
    E 05. Cualquier anomalía o acontecimiento adverso durante la inclusión (la última visita del tratamiento del ensayo EFC14153 será la visita de inclusión) que, según el criterio del investigador, pueda afectar negativamente a la participación del paciente en este ensayo o requerir la interrupción permanente del tratamiento con el PEI. Ejemplos: Pacientes con diagnóstico de infección parasitaria activa (helmintos), riesgo alto o sospecha de infección parasitaria, tuberculosis (TB) activa, infecciones oportunistas invasivas (p. ej. histoplasmosis, listeriosis, coccidioidomicosis, neumocistosis, aspergilosis) a pesar de resolución o infecciones inusualmente frecuentes, recurrentes o prolongadas.
    Pacientes mujeres que han comenzado a tener la menstruación en cualquier momento durante el estudio y son:
    - prueba de embarazo positiva en la orina, o
    -Severamente activo, no usa un método anticonceptivo aceptable establecido.
    Vacunas (vivo y atenuadas) planeadas durante el estudio.
    Pacientes con enfermedad autoinmune activa o pacientes que usan terapia inmunosupresora para la enfermedad autoinmune (p. Ej., Artritis idiopática juvenil, enfermedad inflamatoria intestinal, lupus eritematoso sistémico) en el momento del reclutamiento.
    E.5 End points
    E.5.1Primary end point(s)
    Treatment-emergent-adverse-event (TEAEs): The number (n) and percentage (%) of patients experiencing any TEAEs.
    Número (n) y porcentaje (%) de pacientes que experimenten acontecimientos adversos aparecidos durante el tratamiento (AAAT).
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Day 1 up to Week 64
    Desde el Día 1 hasta la semana 64
    E.5.2Secondary end point(s)
    1) Severe asthma exacerbation events: Annualized rate of severe asthma exacerbation events, during the treatment period
    2) Change in % predicted FEV1: Change in percentage (%) predicted forced expiratory volume in 1 second (FEV1) - Clinically significant changes from baseline
    3) Change in absolute FEV1: Change in absolute FEV1 - Clinically significant changes from baseline
    4) Change in FVC: Change in forced vital capacity (FVC)
    5) Change in FEF: Change in forced expiratory flow [FEF] 25-75%)
    6) Assessment of dupilumab concentration: Serum dupilumab concentrations - Changes from first dupilumab injection
    7) Assessment of immunogenicity: Titers of Anti-dupilumab antibodies
    8) Assessment of blood Eosinophil count: Blood: Eosinophil count
    9) Assessment of immunoglobulins: Serum: Immunoglobulins (Ig)
    10) Assessment of total anti-immunoglobulin E (IgE): Serum: total IgE
    1) Episodios severos de exacerbación del asma: tasa anualizada de episodios graves de exacerbación del asma, durante el período de tratamiento
    2) Cambio en el % (VEF1) previsto: cambio en el porcentaje (%) del volumen espiratorio forzado previsto en 1 segundo (VEF1) - Cambios clínicamente significativos desde el inicio del estudio
    3) Cambio en el VEF1 absoluto: cambio en el VEF1 absoluto - Cambios clínicamente significativos desde el inicio
    4) Cambio en CVF: cambio en la capacidad vital forzada CVF
    5) Cambio en FEF: cambio en el flujo espiratorio forzado [FEF] 25-75%
    6) Evaluación de la concentración de dupilumab: concentraciones séricas de dupilumab - Cambios desde la primera inyección de dupilumab
    7) Evaluación de la inmunogenicidad: títulos de anticuerpos anti-dupilumab
    8) Evaluación del recuento de eosinófilos en sangre: sangre: conteo de eosinófilos
    9) Evaluación de inmunoglobulinas: Suero: Inmunoglobulinas (Ig)
    10) Evaluación de anti-inmunoglobulina E total (IgE): Suero: IgE total
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) From Day 1 up to Week 52
    2) to 10) From Day 1 up to Week 64
    1) Desde el Día 1 hasta la semana 52
    2) hasta 10) Desde el Día 1 hasta la Semana 64
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    Chile
    Colombia
    Hungary
    Italy
    Lithuania
    Mexico
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Turkey
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months90
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months90
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 377
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 327
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    pediatric population
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 83
    F.4.2.2In the whole clinical trial 377
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-13
    P. End of Trial
    P.End of Trial StatusOngoing
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